Regulatory Requirements for Pharmaceuticals
FDA cGMP, J-GMP, PIC/S GMP, API GMP, investigational drug GMP, pharmaceutical excipient GMP, GDP
Gap Analysis
Gap Analysis
It is one method of analyzing the current state.
It is a method of identifying issues: the difference (gap) between the ideal and reality is treated as the challenge, and we analyze what is needed to achieve the ideal.
For example, if the goal is for an ISO9001-certified plant to comply with pharmaceutical GMP, we take pharmaceutical GMP as the ideal, check the differences, and analyze what the plant needs.
Gap Analysis Process
From consultation to reporting and improvement proposals
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01Consultation
We sign a non-disclosure agreement and hear about what you need.
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02Gap Analysis Contract
We conclude a contract with you to conduct the gap analysis.
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03Scheduling the Visit and Debrief
We set the date and time of the visit and the schedule for the gap analysis debrief.
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04Review of Advance Materials
In advance, we review the site overview, manufacturing flow of the products in scope, manufacturing equipment, organization chart and responsibilities, and document system.
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05Agreeing on the Agenda
We send the agenda for the visit and agree on it with you.
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06Plant Visit and Q&A
During the plant visit, we hold Q&A on facilities and systems, and give our feedback on the final day.
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07Submission of the Gap Analysis Report
We submit the gap analysis report (deliverable) within 2 weeks of the analysis.
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08Debrief and Improvement Proposals
At the debrief, we answer any questions about the report and propose improvements.
How We Visit
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Practical gap identification through a mock inspection
Our plant visits are usually conducted as mock inspections.
The assigned consultant plays the role of an inspector from the relevant authority, conducts Q&A, and identifies gaps.
It can also serve as a check of how well you handle an inspection in practice.
On request, the visit can also be conducted in an interview format.
Gap Analysis Fees
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Our sales representative will ask about your situation, and we will quote fees based on the scope, the number of visit days and what is to be reviewed.
Features of Our Gap Analysis
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Conducted by consultants who know both management and hands-on work
Gap analyses are conducted by consultants with management and hands-on experience in areas such as drug products (injectables and solid dosage forms), APIs, medical devices and cosmetics.
To understand your needs correctly, we hold a brief interview beforehand.
Gap Analysis Examples (Regulations and Guidelines Covered)
Regulatory Requirements for Cosmetics
EFfCI, ISO 22716, cosmetics GMP
Regulatory Requirements for Medical Devices
QSR, ISO 13485
Track Record
PERFORMANCE
Explore the projects we have supported so far.
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+81-46-204-5377
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Hours: weekdays 9:00–18:00 (JST)
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